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Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy
Study Purpose
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include:
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
Exclusion Criteria:
- History of allergic to honey, propolis, various pollen, alcohol People with mental disorders or cognitive dysfunction Diabetes mellitus Critical of end of life patientTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Mucositis is common among cancer patients receiving radiotherapy and chemotherapy. A total of 80-100% of the patients are suffering from the mucositis pain; their regular dieting is disturbed, nutritional status deteriorated, and even treatment discontinued. Some self-paid medications like glutamine have been used to prevent mucositis before and during radiotherapy/chemotherapy. However, the cost of glutamine is relatively high (NT15,000 month/person) and its treatment efficacy and side effects are still to be determined. Randomized controlled trials (RCTs) and experiments have shown that honey and propolis may be used for the management of mucositis. Taiwan is a country of rich agriculture with unique bee products among which the longan honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. However, none of these propolis products have been specifically trialed for the management of mucositis of cancer patients. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. Their potential treatment effects have caught the attention of the medical community. Accumulating evidence is supporting the use of bee products in mucositis caused by chemotherapy, radiotherapy, or both. However, systematic review and meta-analysis have suggested a low quality of the included RCTs, and this affects the applicability of the evidence in the real clinical scenario. The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include:
- (1) an analysis of the incidence and severity of mucositis,
severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of
honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring
of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6,
IL-10, and TNF Microbiota in saliva, Microbiota in stool and (4) modeling of the trend of
mucositis for alertness and search of essential parameters of the complications.
In the first year, our project will focus on the analysis of the incidence and severity of mucositis, treatment methods, and treatment costs. In the second year, the planned RCT will be carried out and changes in heart rate, stress, and fatigue of the patients are to be collected using the smart bracelet. In the third year, the investigators will conduct a deep machine learning of the clinical and serial test data to predict the changes in symptoms. The modeling is anticipated to provide important parameter combinations that assist the alerting of possible severe complications. The overall findings of this project shall the strategical references for applying bee products in the prevention and treatment of mucositis in cancer patients.Arms
Experimental: honey
Honey, 10 grams per pack, calories 33.4 calories, protein 0.05 grams, fat 0.07 grams, fructose + glucose 7.0 grams, sodium 0 mg. Usage is three times a day after three meals. After oral care is required before use, use 10 grams of longan honey, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink, or gargle within 30 minutes of use.
Experimental: propolis
Oil-soluble green propolis, propolis 100 mg / mL, dilute green propolis 200 times with edible oil, drink 0.5 mL each time, 3 times a day (a total of 50 mg). Usage: three times a day, after three meals. After oral care is required before use, draw about 0.5ml of green propolis into the mouth, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink or gargle within 30 minutes of use.
Placebo Comparator: control
Routine care to encourage oral care three times a day.
Interventions
Dietary Supplement: - honey
Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
Dietary Supplement: - propolis
Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
Behavioral: - Control
usual care
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Tsai-Wei Huang
[email protected]
+88627361661
For additional contact information, you can also visit the trial on clinicaltrials.gov.
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